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Antibody–Drug Conjugates in the Treatment of Urothelial Cancer
Antibody–Drug Conjugates in the Treatment of Urothelial Cancer
Antibody–drug conjugates (ADCs) have transformed the treatment landscape in oncology and become an essential therape...
Novel Immunotherapeutic Approaches for the Treatment of Glioblastoma
Novel Immunotherapeutic Approaches for the Treatment of Glioblastoma
Glioblastoma is highly aggressive and remains difficult to treat despite being the most common malignant primary brain tum...
Historical Overview of Regulatory Approvals and PMDA Assessments for Biosimilar Products in Japan During 2009–2022
Historical Overview of Regulatory Approvals and PMDA Assessments for Biosimilar Products in Japan During 2009–2022
A biosimilar product is defined as “a biological product that is highly similar to an existing, approved biological ...
Assessing the Interchangeability of AVT02 and Humira® in Participants with Moderate‑to‑Severe Chronic Plaque Psoriasis: Pharmacokinetics, Efficacy, Safety, and Immunogenicity Results from a Multicenter, Double-Blind, Randomized, Parallel-Group Study
Assessing the Interchangeability of AVT02 and Humira® in Participants with Moderate‑to‑Severe Chronic Plaque Psoriasis: Pharmacokinetics, Efficacy, Safety, and Immunogenicity Results from a Multicenter, Double-Blind, Randomized, Parallel-Group Study
The US Food and Drug Administration (FDA) interchangeability guidelines state that the primary endpoint in a switching stu...
CAR-T Cells and the Kidney: Insights from the WHO Safety Database
CAR-T Cells and the Kidney: Insights from the WHO Safety Database
Chimeric antigen receptor T (CAR-T) cells have proven to be a game changer for treating several hematologic malignancies. ...
Advanced Delivery Strategies for Immunotherapy in Type I Diabetes Mellitus
Advanced Delivery Strategies for Immunotherapy in Type I Diabetes Mellitus
Type 1 diabetes mellitus (T1DM) has been defined as an autoimmune disease characterised by immune-mediated destruction of ...
Exploring the Use of Monoclonal Antibodies and Antiviral Therapies for Early Treatment of COVID-19 Outpatients in a Real-World Setting: A Nationwide Study from England and Italy
Exploring the Use of Monoclonal Antibodies and Antiviral Therapies for Early Treatment of COVID-19 Outpatients in a Real-World Setting: A Nationwide Study from England and Italy
Real-world data on early treatment of coronavirus disease 2019 (COVID-19) outpatients with newly approved therapies are sp...
Lupus Nephritis: New and Emerging Biologic and Targeted Therapies
Lupus Nephritis: New and Emerging Biologic and Targeted Therapies
Lupus nephritis (LN) is a severe complication of systemic lupus erythematosus (SLE), a polyclonal systemic autoimmunity di...
Modification of Extracellular Vesicle Surfaces: An Approach for Targeted Drug Delivery
Modification of Extracellular Vesicle Surfaces: An Approach for Targeted Drug Delivery
Extracellular vesicles (EVs) are a promising drug delivery vehicle candidate because of their natural origin and intrinsic...
Review and Update of Active and Passive Immunization Against Respiratory Syncytial Virus
Review and Update of Active and Passive Immunization Against Respiratory Syncytial Virus
Respiratory syncytial virus (RSV) is the most common cause of lower respiratory tract infection (LRTI) in children, causin...
Characterization for the Similarity Assessment between Proposed Biosimilar SB12 and Eculizumab Reference Product Using a State-of-the-Art Analytical Method
Characterization for the Similarity Assessment between Proposed Biosimilar SB12 and Eculizumab Reference Product Using a State-of-the-Art Analytical Method
SB12 is being developed as a proposed biosimilar to eculizumab reference product (RP), a humanized monoclonal antibody (Ig...
Recurring Fatigue After Biologic Administration: Patient-Reported Data from the Dutch Biologic Monitor
Recurring Fatigue After Biologic Administration: Patient-Reported Data from the Dutch Biologic Monitor
Fatigue is a common problem in immune-mediated inflammatory disease (IMID) patients, significantly impacting their quality...
Characterization of a HIR-Fab-IDS, Novel Iduronate 2-Sulfatase Fusion Protein for the Treatment of Neuropathic Mucopolysaccharidosis Type II (Hunter Syndrome)
Characterization of a HIR-Fab-IDS, Novel Iduronate 2-Sulfatase Fusion Protein for the Treatment of Neuropathic Mucopolysaccharidosis Type II (Hunter Syndrome)
Mucopolysaccharidosis type II is a severe lysosomal storage disease caused by deficient activity of the enzyme iduronate-2...
Factors Associated with Biosimilar Exclusions and Step Therapy Restrictions Among US Commercial Health Plans
Factors Associated with Biosimilar Exclusions and Step Therapy Restrictions Among US Commercial Health Plans
Biosimilars have been introduced with the goal of competing with high-priced biologic therapies, yet their adoption has be...
Impact of Introducing Infliximab Biosimilars on Total Infliximab Consumption and Originator Infliximab Prices in Eight Regions: An Interrupted Time-Series Analysis
Impact of Introducing Infliximab Biosimilars on Total Infliximab Consumption and Originator Infliximab Prices in Eight Regions: An Interrupted Time-Series Analysis
We aimed to assess whether the introduction of the first infliximab biosimilar was associated with changes in overall infl...
Correction to: Understanding US Physician and Pharmacist Attitudes Toward Biosimilar Products: A Qualitative Study
Correction to: Understanding US Physician and Pharmacist Attitudes Toward Biosimilar Products: A Qualitative Study
Authors and AffiliationsCenter for Communication Science, RTI International, 3040 Cornwallis Road, Research Triangle Park,...
Six-Year Survival Outcomes for Patients with HER2-Positive Early Breast Cancer Treated with CT-P6 or Reference Trastuzumab: Observational Follow-Up Study of a Phase 3 Randomised Controlled Trial
Six-Year Survival Outcomes for Patients with HER2-Positive Early Breast Cancer Treated with CT-P6 or Reference Trastuzumab: Observational Follow-Up Study of a Phase 3 Randomised Controlled Trial
The Phase 3 CT-P6 3.2 study demonstrated equivalent efficacy and comparable safety between CT-P6 and reference trastuzumab...
Severe Hypersensitivity Reactions at Biosimilar versus Originator Rituximab Treatment Initiation, Switch and Over Time: A Cohort Study on the French National Health Data System
Severe Hypersensitivity Reactions at Biosimilar versus Originator Rituximab Treatment Initiation, Switch and Over Time: A Cohort Study on the French National Health Data System
Biosimilar products of rituximab came to market in 2017. French pharmacovigilance centers have highlighted an excess of ca...
Immunogenicity of Recombinant Adeno-Associated Virus (AAV) Vectors for Gene Transfer
Immunogenicity of Recombinant Adeno-Associated Virus (AAV) Vectors for Gene Transfer
Recombinant adeno-associated viruses (AAVs) have emerged as promising gene delivery vehicles resulting in three US Food an...
Targeting IL-36 in Inflammatory Skin Diseases
Targeting IL-36 in Inflammatory Skin Diseases
Interleukin (IL)-36 cytokines are members of the IL-1 superfamily of cytokines. IL-36 cytokines are composed of three agon...
Serplulimab Plus Chemotherapy vs Chemotherapy for Treatment of US and Chinese Patients with Extensive-Stage Small-Cell Lung Cancer: A Cost-Effectiveness Analysis to Inform Drug Pricing
Serplulimab Plus Chemotherapy vs Chemotherapy for Treatment of US and Chinese Patients with Extensive-Stage Small-Cell Lung Cancer: A Cost-Effectiveness Analysis to Inform Drug Pricing
Serplulimab is a potential valuable therapy, while patients, physicians, and decision-makers are uncertain about the cost-...
Efficacy and Safety of Denosumab Biosimilar QL1206 Versus Denosumab in Patients with Bone Metastases from Solid Tumors: A Randomized Phase III Trial
Efficacy and Safety of Denosumab Biosimilar QL1206 Versus Denosumab in Patients with Bone Metastases from Solid Tumors: A Randomized Phase III Trial
Denosumab has been approved for the treatment of bone metastases from solid tumors. QL1206 is the first denosumab biosimil...
Systematic Literature Review of Economic Evaluations of Treatment Alternatives in Chronic Lymphocytic Leukemia
Systematic Literature Review of Economic Evaluations of Treatment Alternatives in Chronic Lymphocytic Leukemia
Economic evaluations are widely used to predict the economic impact of new treatment alternatives. Comprehensive economic ...
RNA Targeting and Gene Editing Strategies for Transthyretin Amyloidosis
RNA Targeting and Gene Editing Strategies for Transthyretin Amyloidosis
Transthyretin (TTR) is a tetrameric protein synthesized primarily by the liver. TTR can misfold into pathogenic ATTR amylo...
Retention Rate and Safety of Biologic and Targeted Synthetic DMARDs in Patients with RA-Associated Interstitial Lung Disease: A KOBIO Registry Study
Retention Rate and Safety of Biologic and Targeted Synthetic DMARDs in Patients with RA-Associated Interstitial Lung Disease: A KOBIO Registry Study
This study aimed to evaluate the long-term retention and safety of biologic disease-modifying antirheumatic drugs (bDMARDs...
Targeting the Inside of Cells with Biologicals: Toxin Routes in a Therapeutic Context
Targeting the Inside of Cells with Biologicals: Toxin Routes in a Therapeutic Context
Numerous toxins translocate to the cytosol in order to fulfil their function. This demonstrates the existence of routes fo...
Comparative Safety Profiles of Oncology Biosimilars: A Systematic Review and Network Meta-analysis
Comparative Safety Profiles of Oncology Biosimilars: A Systematic Review and Network Meta-analysis
It is crucial that the safety profiles of biosimilars are similar to those of the original biologics. A better understandi...
Consistency of Product Quality for SB5, an Adalimumab Biosimilar
Consistency of Product Quality for SB5, an Adalimumab Biosimilar
Biologics, regardless of whether they are biosimilars or reference products, are inherently variable due to their size, co...
Copies of Biological Medicines: Similar But Not the Same?
Copies of Biological Medicines: Similar But Not the Same?
The article of Klein et al. [4] in this issue of BioDrugs describe a cross-sectional overview of copy biologicals approved...
Current Progress and Challenges in the Study of Adjuvants for Oral Vaccines
Current Progress and Challenges in the Study of Adjuvants for Oral Vaccines
Over the past 20 years, a variety of potential adjuvants have been studied to enhance the effect of oral vaccines in the i...
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